Acute Ischemic Stroke AIS
Conditions
Keywords
Ischemic Stroke, Thrombectomy
Brief summary
The purpose of this clinical trial is to study the two main types of approaches used in stroke thrombectomy and to investigate if one approach is more effective than the other, as this is currently not known. This study will be conducted in adults who have been diagnosed with an acute ischemic stroke and who are undergoing a thrombectomy for the treatment of their stroke. The main questions it aims to answer are: * Does the use of a balloon guide catheter versus a conventional guide catheter lower the time needed to restore blood flow in the blocked vessel in the brain * To help researchers better understand the technical, clinical, and procedural outcomes associated with using a balloon guide catheter versus a conventional guide catheter in stroke thrombectomy Participants will be asked to * Share their medical history and imaging data that is collected as part of their routine medical care * Undergo a mechanical thrombectomy as part of their routine medical care * Answer some questions about their neurological functioning at 3 months (90 days) post hospitalization
Interventions
OTHERUse of a Balloon Guide Catheter
Use of a balloon guide catheter in stroke thrombectomy.
OTHERUse of a Conventional (non-balloon) Guide Catheter
Use of a conventional (non-balloon) guide catheter in stroke thrombectomy.
Sponsors
University of South Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Patient is undergoing a stroke thrombectomy procedure at the enrolling hospital * Patient or the legally authorized representative are able to provide signed informed cosent for the study * Patient is not enrolled in another clinical trial that may interfere with the results or interpretation of this study * Identification of a Large Vessel Occlusion (LVO) on imaging
Exclusion criteria
* Lack of signed informed consent from the patient or legally authorized representative * Spontanous recanalization or any other reason in which the mechanical thrombectomy procedure would be terminated
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TICI Grading Scale Score | Participant duration is 90 days. | Use of a mTICI grading scale to look at the degree to which the vessel has been opened during a mechanical thrombectomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural Outcomes | Participant duration is 90 days. | Metrics associated with a standard of care thrombectomy procedure, such as length of procedure, will be collected. |
| Number of Participants with Treatment Related Adverse Effects | Participant duration is 90 days. | Collection of data related to clincial and safety outcomes such as presence of a bleed. |
Countries
United States
Outcome results
None listed